Long before any pharmaceuticals or medical devices reach the patients or the healthcare professionals who depend on them, the systems, equipment, processes, and methods behind developing, producing, and testing them must be validated to ensure they function as intended.
Regulatory compliance requirements extend throughout the full product life cycle. Violations of regulatory compliance regulations often results in legal challenges. Starting from development through approval, manufacturing, launch, and required post market reporting, STS will help develop strategy in place to help manage the regulatory compliance.
Preclinical studies during the early phases of development plays an essential part in the approval of any product. STS Pre-clinical services help investigators to accelerate new medical product development in the academic setting and enhance the opportunities for their commercialization. STS guides the investigator to assemble a nonclinical data package (e.g., pharmacology, pharmacokinetics, and product characterization) that will support the regulatory requirements for initiation of clinical trials.
Quality management is a multidimensional issue, covering more than just verification that a finished product meets certain expectations.
Product manufacturing inevitably faces ongoing risks to finances, products, data, equipment, property, and personnel.
Efficient collecting, transferring, and managing of data during a preclinical and clinical trial is crucial to advance the development process
Aid in turning your invention idea into marketable product.
Aid in introducing product to global market and assist in launching product on global platforms
With globalization, future trends and market value of the product needs in-depth analysis for business growth
From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. STS digitalization experts can help you with your digital health products.
Automation of regulatory procedures can intensely improve the efficiency and productivity of manufacturers. Process automation can not only save time but also ensure that the product is manufactured in consistent manner with utmost reproducibility.
Our training goal is to maximize your potential and enhance your performance to help you reach your goals. STS will work with you during all phases of the career development process and provides career development resources at any junction of your career, be it early career development or intermediate skill enrichment.